PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR TROPONIN T HS (HIGH SENSITIVE), ELECSYS PROBNP II IMMUNOASSAY (PROBNP II), ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS ANTI-HBS II, AND ELECSYS BRAHMS PCT ON A COBAS 8000 E 602 MODULE. BASED ON THE INFORMATION PROVIDED, PROBNP II RESULTS WERE DISCREPANT WHEN COMPARED TO THE ABBOTT ARCHITECT METHOD. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT (CHILD, (B)(6)) WAS ADMITTED TO THE PEDIATRIC CARE INTENSIVE CARE UNIT OF THE HOSPITAL ON (B)(6) 2017 FOR "INSUFFICIENCY ACUTE HEART AND COMA." THE PATIENT HAD A DELAY OF PSYCHOMOTOR DEVELOPMENT AND WAS RECEIVING ENTERAL NUTRITION BY GASTROSTOMY. THE PROGRESSION OF THIS CONDITION BEGINS WITH VOMITING AFTER ENTERAL NUTRITION FOLLOWED BY RESPIRATORY DISTRESS UPON INHALATION. ON (B)(6) 2018 THE TROPONIN T HS RESULT FROM THE E602 MODULE WAS 249 NG/L AT 12:13 A.M. THE PROBNP II RESULT FROM THE E602 MODULE AT THE SAME TIME WAS 10,488 NG/L. A NEW SAMPLE WAS OBTAINED AT 5:30 P.M. AND THE TROPONIN T HS RESULT FROM THE E602 MODULE WAS 167 NG/L AND THE PROBNP II RESULT WAS >35,000 NG/L. AT 11:15 P.M. THE PROBNP II RESULT WAS 34,611 NG/L. IT WAS SUSPECTED THAT THE PATIENT HAD MITOCHONDRIAL CYTOPATHIES AND TREATMENT WAS STARTED. THE PATIENT'S TREATMENT SCHEDULE WAS PG5%, MEDIA LIPIDS, VITAMINS B1, B8 AND B9 AND CO-ENZYME Q10. BIOTIN TREATMENT WAS ALSO STARTED AT 8:00 P.M ON (B)(6) 2018. ON (B)(6) 2018 A NEW SAMPLE WAS OBTAINED AND ADDITIONAL TESTS WERE RUN. AT 5:30 A.M. THE PATIENT HAD A PROBNP II RESULT OF 40 NG/L ON THE E602 MODULE. DUE TO THE PRO-BNP II RESULTS, THE CUSTOMER SUSPECTED A BIOTIN INTERFERENCE. ON (B)(6) 2018 THE SAMPLE FROM (B)(6) 2018 WAS TESTED BY THE ABBOTT ARCHITECT METHOD AND THE BNP RESULT WAS 153 PG/ML. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. NO ADVERSE EVENT OCCURRED DUE TO THE DEVICE. THE E602 MODULE SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

NO SAMPLES FROM THE PATIENT WERE AVAILABLE FOR ANALYSIS. SINCE NO SAMPLE MATERIAL COULD BE PROVIDED, THE CUSTOMER'S SUSPICION OF A BIOTIN INTERFERENCE COULD NOT BE INVESTIGATED. FROM THE INFORMATION AVAILABLE, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.